September 5, 2001 01-35RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-503-1, Vastland brand Taro(TM) Wafers, packed in flexible plastic packages, net wt. 200 grams, all codes including QB 1433.7. REASON: The product contained undeclared peanuts and brilliant blue FCF (certifiable as FD&C Blue No. 1) and amaranth (formerly known as FD&C Red No. 2), a color that was delisted and is no longer authorized for use in foods. The product’s label did not list peanuts as an ingredient and only listed “Food Colour” as an ingredient without specifying the colors in the product. MANUFACTURER: Tung Kuan Vastland Food Products Co., Ltd. Hong Kong, China RECALLED BY: Strong America Limited Brooklyn, NY (importer). Strong America issued an “Allergen Alert” on 3/2/00. Importer sent recall letter on 10/2/00 to retail customers. FIRM INITIATED RECALL: Completed. Recall resulted from inspection and analysis by New York State Dept. of Agriculture & Markets. DISTRIBUTION: NY (9), MA (4), FL (1). QUANTITY: 19 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-504-1, Goldensmell brand Candy (Sucker Candy) packed in flexible plastic packages, net wt. 5 oz. (140 grams), all codes including "BEST BEFORE 2001 01 19". REASON: The product contained undeclared peanuts and undeclared colors, i.e., tartrazine (certifiable as FD&C Yellow No. 5), sunset yellow FCF (certifiable as FD&C Yellow No. 6), brilliant blue FCF (certifiable as FD&C Blue No. 1), and allura red AC (certifiable as FD&C Red No. 40). MANUFACTURER: Yik Hoi Trading Co. To Kwa Wan, Kowloon, Hong Kong, RECALLED BY: Strong America Limited Brooklyn, NY (importer). Strong America issued an "Allergy Alert" on 5/12/00. Importer sent "Recall Notice" on 10/2/00 to retail customers. FIRM INITIATED RECALL: Completed. Recall resulted from inspection and analysis by New York State Dept. of Agriculture & Markets. DISTRIBUTION: NY (8) and FL (1). QUANTITY: 42 cases ______________________________ RECALL NUMBER, PRODUCT AND CODE: F-505-1, Vastland brand Lemon(TM) Wafers, packed in flexible plastic packages, net wt. 200 grams, all codes including QB 1433.7. REASON: The product contained undeclared peanuts and undeclared colors, i.e., tartrazine (certifiable as FD&C Yellow No. 5) and sunset yellow FCF (certifiable as FD&C Yellow No. 6). RECALLED BY: Strong America Limited Brooklyn, NY (importer). Strong America Ltd. issued an "Allergen Alert" on 5/12/00. Importer sent "Recall Notice" on 8/5/00 to retail customers. FIRM INITIATED RECALL: Completed. Recall resulted from inspection and analysis by New York State Dept. of Agriculture & Markets. DISTRIBUTION: NY (10), FL (1), MA (3), IL (1). QUANTITY: 70 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-506-1, STR brand "Uncovered Huasheng" packed in flexible plastic packages, barcode # 643806 884018 and no other coding. REASON: The product contained undeclared peanuts. MANUFACTURER: Strong America Limited Brooklyn, NY (repacker). RECALLED BY: Manufacturer, letter to its retail customers on 5/19/00. FIRM INITIATED RECALL: Completed. Recall resulted from inspection and analysis by New York State Dept. of Agriculture & Markets. DISTRIBUTION: NY (15), CT (1), MA (2), PA (2) and IL (1). QUANTITY: 48 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-507-1, Vastland brand Cantaloup Melon(TM) Wafers packed in flexible plastic bags, net wt. 200 grams, all codes including QB 1433.7, barcode # 6914375 604067. REASON: The product contained undeclared peanuts, and the uncertified color additive tartrazine (certifiable as FD&C Yellow #5). MANUFACTURER: TungKuan Vastland Food Products Co., Ltd., Humen Town Tung Kuan City Guang Tung Prov, China RECALLED BY: Strong America Limited Brooklyn, NY (importer). Strong America issued an “Allergen Alert” on 6/12/00. On 7/3/00, Strong America issued a second "Allergen Alert" to cover recalled product distributed to Massachusetts, Pennsylvania and Georgia. Importer sent recall letters on 10/2/00 to retail customers. FIRM INITIATED RECALL: Completed. Recall resulted from inspection and analysis by New York State Dept. of Agriculture & Markets. DISTRIBUTION: NY (8), MA (4), PA (1), IL (1), GA QUANTITY: 93 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-508-1, Goldensmell brand Candy (Wanxing Candy) packaged in flexible plastic bags, net wt. 11.7 oz. (328 g), barcode # 6 43806 89046 0. REASON: The product contained undeclared peanuts. MANUFACTURER: Yik Hoi Trading Company, Hong Kong, China RECALLED BY: Strong America Limited Brooklyn, NY (importer). Strong America issued an "Allergen Alert" on 7/11/00. Importer reportedly sent a recall letter to the retail customers that same day. As there was no documentation or responses available, NYSDAM requested the firm send another recall notification letter. The recall letter was sent on 10/2/00. FIRM INITIATED RECALL: Completed. Recall resulted from inspection and analysis by New York State Dept. of Agriculture & Markets. DISTRIBUTION: New York, NY (2) and in Flushing, NY (1). QUANTITY: 4 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-513-1, Deluxe Deviled Crabs; F-514-1, Deluxe Crab Rounds. CODES: No codes are used on the product. REASON: The products contain undeclared egg whites. MANUFACTURER: Herky's Food Product, Inc. Pittsburgh, PA RECALLED BY: Manufacturer, by telephone on 3/8/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA, OH, WV QUANTITY: Unknown ______________________________ RECALL NUMBER, PRODUCT AND CODE: F-515-1, Veggie Platter with Peppercorn Ranch Dip, #98923, Net Wt 108 oz (6.75 Lb), Kirkland (tm), CODES: Product number #98923, purchased from 2/3/2001 to 2/8/2001. REASON: The platters were manufactured using cut red bell peppers that were contaminated with Listeria monocytogenes. MANUFACTURER: Distributed by Costco Wholesale Corp., Seattle, WA. RECALLED BY: Costco Wholesale Corporation, Issaquah, WA, by recall letter and press release dated 2/8/2001. FIRM INITIATED RECALL: Completed DISTRIBUTION: Southern California. QUANTITY: 200 pounds of Red Peppers, for estimated 400 platters. _____________________________ RECALL NUMBER, PRODUCT AND CODE: F-516-1, Dragon brand Dried Sweet Potato in flexible plastic bags, net wt. 6 oz. (170g). Product of China. REASON: The product contained undeclared sulfites MANUFACTURER: Xinhui Sun Woo Foodstuff Mill Taichi, Xinhui, Guangdong. RECALLED BY: Sincere Trading Co., Inc. Brooklyn, NY (importer). Importer sent "Urgent Voluntary Recall Notice" on 1/29/01 to retail customers. FIRM INITIATED RECALL: Completed. Recall resulted from sampling & analysis by State of Florida. DISTRIBUTION: Retail stores in NY (2), MA, (2), PA (1), IL (5), MI (2), MD (2), Fl (3), GA (1) QUANTITY: 26 Cases _____________________________ RECALL NUMBER, PRODUCT AND CODE: Frozen sandwiches labeled in part Chartwells Thompson Hospitality Sandwich, For Institutional Use Only, Dist. by La Morenita, The Authentic Taste of Mexico, Chicago, IL ; the following sandwiches were distributed: a) F-517-1 item #1108, Turkey Salami, Turket Bologna & Cheese on Lamore Bread, packed 40 - 4.7 oz sanwiches per case, Net Wt. 11 lbs. 12 oz., UPC #27232-01108 b) F-518-1 item # 1105, Turkey Salami on Hamburger Bun, packed 40 - 5.3 oz. sandwiches per case, New Wt. 13 lbs. 4 oz., UPC #27232-01105 c) F-519-1 item # 1103, Turkey Bologna on White Bread, packed 40 - 3.8 oz. sandwiches per case, Net Wt. 9 lbs. 8 oz., UPC #27232-01103 d) F-520-1 item # 1101, Turkey Ham on Wheat Bread, packed 40 - 5.2 oz. sandwiches per case, Net Wt. 13 lbs., UPC #27232-01101 e) F-521-1 item # 1109, Turkey Roll and Cheese on White Bread, packed 40 - 4.8 oz. sandwiches per case, Net Wt. 12 lbs., UPC #27232-01109 Codes: a) item #1108, lots PKD3430, PKD3350, PKD3440 b) item #1105, lots PKD3350, PKD3430 c) item #1103, lots PKD3370, PKD3460 d) item #1101, lots PKD3360, PKD3370, PKD3480 e) item #1109, lots PKD3430, PKD3440 REASON: The sandwiches were contaminated with Listeria monocytogenes MANUFACTURER: La Morenita, Inc. Chicago, IL RECALLED BY: Manufacturer, by press release on 1/26/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1027 Cases _____________________________ RECALL NUMBER, PRODUCT AND CODE: F-522-1, Dianne's Gourmet Desserts Mountain Berry Cream Flan, Net weight 56 oz, (per case of 4 flans). CODE: 08801. REASON: The product was contaminated with Listeria monocytogenes. MANUFACTURER: Royal American Foods, Inc., MN RECALLED BY: Manufacturer, by telephone on April 2, 2001, and letter on April 11, 2001. FIRM INITIATED RECALL: Completed DISTRIBUTION: FL, IL, KY, MI, MN, NY, OK, PA, WA QUANTITY: 107 cases _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-524-1, Jane's Broccoli Stromboli. The product is a broccoli and cheese stromboli, and is sold frozen. CODE: No codes are used. REASON: The product contained undeclared eggs. MANUFACTURER: Jane's Stromboli, Stoneboro, PA RECALLED BY: Manufacturer, by press release on 5/2/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA QUANTITY: 10987 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: F-530-1, Jungles Jammers Brand Animal Crackers, Codes: 01302C, 02012A,02012B, 02232B,02232C, 02242A REASON: The product contained undeclared milk and eggs. MANUFACTURER: DF Stauffer Biscuit, York, PA RECALLED BY: Manufacturer, by press release on 6/11/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA, FL, GA, IN, KY, MD, MI, MO, NY, OH, TN, TX QUANTITY: 8168 Cases (98,016 units)RECALLS AND FIELD CORRECTIONS: Foods -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: F-464-1, American Curly Parsley. Labeled "JF CALIFORNIA FRESH PRODUCE***5 DOZ CURLY PARSLEY***PACKED SHIPPED BY JIMENZE FARMS***Oxnard, CA 93041" REASON: This product was contaminated with shigella. MANUFACTURER: Jimenez Farms, Hueneme, CA RECALLED BY: Manufacturer, by telephone and via letter on 6/29/2001. FIRM INITIATED RECALL: Completed DISTRIBUTION: CA QUANTITY: 96 casesRECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
_______________________________ RECALL NUMBER, PRODUCT AND CODE: D-288-1 MSM Eyes and Nasal Drops, a liquid, packaged in white plastic 1 fluid oz eye drop bottles with a purple and pink label. The product is labeled in part:"***MSM Eyes and Nasal Drops***All That's Natural II***1 fl. oz.***Contains: Distilled water adjusted to .09% Saline (from Sea Salt) and MSM, a fundametal source of nutritional sulfur.***Suggested Use: Use as needed to relieve irritated, sore, or itchy eyes or nasal passages.***Distributed by: All That's Natural II, Inc. 1-800-700-7477 www.atnmsm.com***" The product is an OTC eye and nasal drop containing methylsulfonylmethane. Codes: All lots and codes REASON: MICROBIAL CONTAMINATION (Pseudomonas mendocina/Klebsiella pneumoniae). MANUFACTURER/RECALLING FIRM: Allure Cosmetic, Inc. Hayward, CA. RECALLED BY: All That's Natural II, Inc. Gardena, CA ., by letter dated 06/25/01. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: U.S. and Hawaii, Alaska, Puerto Rico, American Samoa, and Washington, DC. AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MD, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. QUANTITY: 44,000. _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-289-1 MSM Eyes Drops, 1 fl. oz. The product is an OTC eye and nasal drop containing methylsulfonylmethane, MSM, packaged under the brand name "UB Ultra Botanicals MSM Eye Drops". The liquid is packaged in white plastic 1 fluid oz eye drop bottles with a purple label. The product is labeled in part:"***UB ULTRA BOTANICALS MSM EYE DROPS***1 FLUID OZ***Dosage: Two drops per eye daily. Use more often for chronic conditions.***Contains: 5% MSM, (methylsulfonyl-methane) solution in distilled water and .09% saline derived from Natural Sea Salt.***Exclusively Manufactured For: ULTRA BOTANICALS, Inc. P.O. Box 2266. Los Angeles, CA 90064***". CODES: All codes and lots. REASON: MICROBIAL CONTAMINATION (Pseudomonas mendocina/Klebsiella pneumoniae) MANUFACTURER/RECALLING FIRM: Allure Cosmetic Inc. Hayward, CA. RECALLED BY: Ultra Botanicals, Inc. Los Angeles, CA, by telephone. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MD, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and Washington, DC. Three bottles have been sold to a single consignee in Belgium. QUANTITY: 18,026.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: D-059-1 (Extension to D-059-1) Tegretol® Tablets (carbamazepine), 200 mg, LOT NOS 232E9126—bottles of 1,000 tablets REASON: Dissolution failure. MANUFACTURER/RECALLING FIRM: Novartis Pharmaceutical Corp., Suffern, NY. RECALLED BY: Novartis by letter on August 9, 2001 FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide QUANTITY: 3,238 bottles. _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-280-1 Clonidine HCI, USP, in bottles labaeled as containing 1, 5, or 25 grams per bottle. The bottles of drug are also labeled as packaged by Universal Chemical, St. Peter, MN 56082. CODES: Lot UC99021002, packaged 02/99, CAS: 4205-90-7 and Lot UC99021002A, CAS #4205-91-8. REASON: Current Good Manufacturing Practice Deviation-Production Records Do Not Correspond to Amounts of Product Distributed. MANUFACTURER (bulk drug): Toning Limited Corporation Nanjing, China. RECALLED BY: Hawkins Chemical Inc., Minneapolis, MN., by letter dated June 20,2001. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide QUANTITY: 75 1-gram bottles; 79 5-gram bottles, and 22 25 gram bottles. _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-294-1 VANCERIL 42 MCG (BECLOMETHASONE DIPROPIONATE) INHALATION AEROSOL, 16.8g -200 metered actuations per canister. CODES: Lot No. Expiration Date 1-AMA-202 FEB 2003 1-AMA-203 FEB 2003 1-AMA-204 FEB 2003 1-AMA-205 FEB 2003 REASON: POTENCY; Lack of assurance that canisters/product can meet specifications (high or low) MANUFACTURER/RECALLING FIRM: Schering Corp. Kenilworth, NJ. RECALLED BY: Manufacturer, by letter on 7/13/2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: 44 states nationwide. QUANTITY: 322,644 canisters.RECALLS AND FIELD CORRECTIONS: DRUGS-- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: D-269-1 White with Blue Specks. Caffeine tablets, 150 mg. The product is sold in 100 count and 500 count bottles. The label states manufactured for: Pittsburgh Pill Emporium, Pittsubrg, PA or Casey’s Distributors, Williamsport, PA. The Casey labeled product is only for the 100 count size. The Pittsburgh Pill labeled product is for both the 100 and 500 count size. CODE: Lot #6076 exp. 2/02. REASON: STABILITY: There is no data to support labeled expiry date. MANUFACTURER/RECALLING FIRM: Nittany Pharmaceuticals, Inc., Milroy, PA. RECALLED BY: Manufacturer, by telephone and letter on 6/27/01. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: PA. QUANTITY: 142 bottles. _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-271-1 Overtime Stimulant tablets, 200 mg caffeine, sold in 100 count and 500 count bottles. The label states that the product is distributed by BDI Pharmaceuticals, A Division of Body Dynamics Inc., Carmel, IN. CODES: Lot 6085 exp. 7/01 and Lot 10362 exp. 2/03. REASON: STABILITY: There is no data to support labeled expiry date. MANUFACTURER/RECALLING FIRM: Nittany Pharmaceuticals, Inc., Milroy, PA. RECALLED BY: Manufacturer, by telephone and letter on 6/27/01. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: IN. QUANTITY: 125 bottles. _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-276-1 Monsel Solution (Ferric Subsulfate Solution), sold in an 8 ml vial in cases of 12 vials. CODE: Lot #57952 exp. 1/02. REASON: Super-Potent for Iron Content. MANUFACTURER/RECALLING FIRM: Dercher Enterprises, Inc., Upper Darby, PA. RECALLED BY: Premier Medical Products, King of Prussia, PA, by telephone and letter on 9/28/01. FIRM INITIATED RECALL: Complete. DISTRIBUTION: CA, CT, IA, IL, IN, MD, ME, MI, MN, MO, ND, NY, OH, PA, and WA. QUANTITY: 450 dozen. _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-278-1 Vioxx 50 mg Tablets (Rofecoxib Tablets), NDC 0006-01124-68, solid oral dosage form, packaged in plastic bottles/plastic lid of 100. CODE: Lot No. Exp. Date J9310 Nov-01 J9311 Nov-01 J9312 Nov-01 J9313 Nov-01 J9314 Nov-01 K2013 Aug-01 K2014 Aug-01 K2015 Mar-02 K2016 Mar-02 K2021 Mar-02 K2022 Mar-02 K2026 May-02 K2031 May-02 K2033 May-02 K2034 May-02 K2036 Mar-02 K2037 Nov-02 K2708 Nov-02 K2709 Nov-02 L3164 Nov-02 L3165 Nov-02 L3166 Nov-02 L3174 Nov-02 L3175 Jan-03 L3176 Jan-03 L3179 Jan-03 L3180 Jan-03 L3181 Jan-03 L3182 Feb-03 REASON: MISLABELING; Product fails to declare container is a bulk package not intended for dispensing and not child resistant. MANUFACTURER/RECALLING FIRM: Merck Sharp & Dohme Quimica de PR (Arecibo Pharmaceutical Operation), Arecibo, PR. RECALLED BY: Manufacturer, by letter on June 28, 2001. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide. QUANTITY: 622,427 units. _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-279-1 PTE-4, Pediatric, A Mixture of Four Trace Elements Injection; for I.V. use only after dilution; a supplement to intravenous solution given for TPN; 3 mL fill in 6.5 mL single dose vial; American Pharmaceutical Partners, Inc., Los Angeles, CA 90024; product code 8203,NDC #63323-082-03. CODE: lot number 100355, exp. 4-02. REASON: Super-Potent for Chromium Ingredient (12 Month Stability Testing). MANUFACTURER/RECALLING FIRM: American Pharmaceutical Partners, INC., Melrose Park, IL. RECALLED BY: Manufacturer, by letter dated 7/18/01. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide and Canada. QUANTITY: 78,925 vials. _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-293-1 Oxygen USP, Compressed, The product is in 180 liter aluminum cylinder tanks. The product label states "Oxygen USP***Produced by Air Liquefaction***Oxycare***120 Sibley Ave***Ardmore, PA 19003" Codes: Lot # 06 25 011 exp. 1/06 REASON: Sub-Potent MANUFACTURER/RECALLING FIRM: OxyCare, Inc. Ardmore, PA RECALLED BY: Manufacturer, by telephone on 8/15/01. FIRM INITIATED RECALL: Complete. DISTRIBUTION: PA and NJ QUANTITY: 12 cylinders. _______________________________ RECALL NUMBER, PRODUCT AND CODE: D-295-1 LITHOBID (Lithium Carbonate, USP) Slow-Release Tablets Bottles of 100 tablets - The product contains lithium carbonate, USP solid-release 300 mg. tablets. Expiration Date July 2001 Codes: Lot 90574, Expiration July 2001 REASON: Dissolution Failure MANUFACTURER/RECALLING FIRM: Solvay Pharmaceuticals, Inc. Baudette, MN. RECALLED BY: Solvay Pharmaceuticals, Inc. Marietta, GA , by letter on July 25, 2001. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide QUANTITY: 14,480 units.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1329-1 Platelets , M30669, M31111, M31418, S61759 B-1330-1 Fresh Frozen Plasma, M30669, M131111, M31300 REASON: Blood products, collected from donors who had taken a category X medication, were distributed. MANUFACTURER: Michigan Community Blood Centers, Grand Rapids, MI RECALLED BY: Manufacturer, by facsimile or letters on 11/29/00 FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY: 7 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1332-1, Amicus Separator Apheresis Instrument with software version 2.50 REASON: Blood collection device may return an inappropriate volume of plasma to a donor during an apheresis procedure. MANUFACTURER: Baxter Healthcare Corporation, Largo, FL RECALLED BY: Baxter Healthcare Corp., Round Lake, FL, by letters and facsimiles dated May 31, 2001 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and internationally QUANTITY: 184 Units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1776-1 Source Plasma Unit 4GG923A REASON: Blood product, collected from a donor who had been incarcerated, was distributed. MANUFACTURER/RECALLING FIRM: Centeon Bio-Services, Kansas City, MO RECALLED BY: Manufacturer by facsimile on March 2, 1999 FIRM INITIATED RECALL: Complete DISTRIBUTION: UK QUANTITY: 1 unit ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1782-1 Red Blood Cells, Leukoreduced , Unit 15-0102747. REASON: Blood product, collected from a donor taking Aricept (Donepezil Hydrochloride), was distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Midland, TX. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by letter dated December 6, 2000. FIRM INITIATED RECALL: Complete. DISTRIBUTION: TX. QUANTITY: 1 unit. ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1786-1, Platelets, Pheresis, Leukoreduced, Irradiated, Unit C10190 REASON: Blood product, for which documentation of irradiation was incomplete, was distributed. MANUFACTURER: Aurora Area Blood Bank, Aurora, IL RECALLED BY: Manufacturer, by letter dated May 29, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 unit ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1787-1, Red Blood Cells Units GJ64116, GJ61664 B-1788-1, Recovered Plasma Units GJ64116, GJ61664 REASON: Blood products, which tested negative for the antibody to the human immunodeficiency virus type 1/2, but were collected from a donor who previously tested repeatedly reactive for the antibody, Western Blot indeterminate for HIV-1, were distributed. MANUFACTURER: Tri-Counties Blood Bank, Santa Barbara, CA RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by facsimiles dated December 13, 2000, and letters dated June 22, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 4 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1820-1, Red Blood Cells, Leukoreduced , Unit 12449-7666 REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Albuquerque, NM RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by letter dated June 6, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: New Mexico QUANTITY: 1 unit ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1825-1 Red Blood Cells , Unit #1856960 B-1826-1, Recovered Plasma, Unit #1856960 REASON: Blood products, that tested negative for antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive to anti-HCV, were distributed. MANUFACTURER/RECALLING FIRM: LifeShare Blood Centers, Shreveport, LA RECALLED BY: Manufacturer, by letter dated July 22, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: LA, CA QUANTITY: 2 units ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1827-1, Platelets, Unit #1767543 REASON: Blood product, that tested negative for antibody to human immunodeficiency virus (anti-HIV), but was collected from a donor that previously tested repeatedly reactive to anti-HIV, was distributed. MANUFACTURER: LifeShare Blood Centers, Shreveport, LA RECALLED BY: Manufacturer, by letter on December 1, 1998. FIRM INITIATED RECALL: Complete DISTRIBUTION: MI QUANTITY: 1 unit ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1829-1, AlloDerm Acellular dermal graft for human transplantation, Lot B0856, Repliform Tissue Regeneration Matric, Lot B0856 REASON: Human tissue for transplant, collected from a donor in which HIV-1 PCR testing detected HIV DNA, were distributed. MANUFACTURER/RECALLING FIRM: LifeCell Corporation, Branchburg, NJ RECALLED BY: Manufacturer, by telephone on January 16, 2001 and letters dated 23, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NY, CA, MA and NC QUANTITY: 18 pieces ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1853-1, Red Blood Cells, Irradiated, Unit 08V00125 REASON: Blood product, for which documentation of irradiation was incomplete, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, San Jose, CA. RECALLED BY: Manufacturer, by letter dated September 17, 1998. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1854-1, Platelets, Pheresis, Unit 08LG05773 REASON: Blood product, with elevated platelet count, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, San Jose, CA RECALLED BY: Manufacturer, by letter dated March 2, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1862-1, Platelets Pheresis, Leukocytes Reduced, Unit #08LG05369 REASON: Platelets with a decreased platelet count were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, San Jose, CA RECALLED BY: By letter dated January 29, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1864-1, Platelets Pheresis, Leukocytes Reduced, Unit #08LG03414 REASON: Blood product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, San Jose, CA RECALLED BY: By letter dated October 1, 1998. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unit ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1865-1, Platelets Pheresis, Leukocytes Reduced, Unit #G17870 REASON: Blood product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed. MANUFACTURER/RECALLING FIRM: Northern Illinois Blood Bank, Inc., Rockford, IL RECALLED BY: By letter dated May 16, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 unit ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1866-1, Red Blood Cells, Unit #07FK52916 REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Tucson, AZ RECALLED BY: By letter dated December 13, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1867-1, Red Blood Cells, Unit #03FH08587 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Atlanta, GA RECALLED BY: By letter dated September 26, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: Georgia QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1868-1, Red Blood Cells Unit 49Y76410 B-1869-1 Platelets, Unit 49Y76410 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Tulsa, OK RECALLED BY: By letter dated March 8, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX, OK QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1870-1 Red Blood Cells, Leukocytes Reduced, Unit #10628-1398 B-1871-1 Platelets, Irradiated, Unit #10628-1398 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Chandler, AZ RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by letter dated December 29, 2000, and by telephone on May 3, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 2 units ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1872-1, Red Blood Cells, Unit #10624-4780 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Scottsdale, AZ RECALLED BY: By letter dated January 8, 2001 FIRM INITIATED RECALL: Complete DISTRIBUTION: Arizona, QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1873-1, Red Blood Cells, Leukocytes Reduced, Unit #’s 10617-2151, 10623-5350, and 10629-2757 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Scottsdale, AZ RECALLED BY: By telephone on September 10, 2000, and by letter dated October 19, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 3 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1874-1 Red Blood Cells, 10621-4143 B-1875-1 Platelets, 10621-4143 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Scottsdale, AZ RECALLED BY: By letter dated December 19, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 2 units ________________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1876-1, Red Blood Cells (2 units), Unit 36259-2121 (two split units) REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Ventura, CA RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by letter dated December 20, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 2 units ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1877-1, Red Blood Cells, Unit 10625-7923 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc.,Mesa, AZ RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by letter dated September 14, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1878-1, Red Blood Cells,Unit #0345010 and 0351621 B-1879-1, Platelets, Unit #0345010 REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. MANUFACTURER/RECALLING FIRM: Community Blood Bank of Erie County, Erie, PA RECALLED BY: By facsimile on December 8, 2000, and by letter on December 12, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA QUANTITY: 3 units ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1880-1, Red Blood Cells, Unit #5291156 REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. MANUFACTURER/RECALLING FIRM: Carter BloodCare, Bedford, TX RECALLED BY: By telephone on April 30, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: TX QUANTITY: 1 unit ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1883-1, Red Blood Cells, Unit #084FT13479 REASON: Blood product, collected from a donor whose hematocrit was not determined, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Oakland, CA RECALLED BY: By telephone on August 6, 1999 and by letter dated September 5, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1710-1, Mumps Skin Test Antigen USP, 0.1 ml, Lot U0225AA REASON: Results of routine stability testing conducted by the manufacturer found that the potency of the lot had fallen below the product specification prior to the product’s expiration date. MANUFACTURER/RECALLING FIRM: Aventis Pasteur, Inc., Swiftwater, PA RECALLED BY: By letter November 13, 2000 FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide QUANTITY: 16, 354 vials _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1785-1, Red Blood Cells, Leukoreduced, Unit 04K36308 REASON: Blood product, collected from a donor with a history of Idiopathic Thrombocytopenic Purpura, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Dedham, MA RECALLED BY: By letter dated April 13, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NH QUANTITY: 1 Unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: a) B-1823-1 Platelets, Unit numbers: 50C01823, 50C01825, 50C01834, 50LG33157, 50C01809, 50LG33178, 50C01839, 50C01846, 50C01856, 50C01863, 50LG33160, and 50LG33180 b) B-1824-1, Platelets Irradiated, Unit numbers: 50LG33254, 50LJ23586, 50C01764, 50LG33120, 50LJ23494, 50LJ23505, and 50LJ23519 REASON: Platelets, not stored under continuous agitation, were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Toledo, OH RECALLED BY: By letter dated January 17, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: OH QUANTITY: a) Platelets (12 units) b) Platelets Irradiated (7 units) 19 units ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1848-1, Red Blood Cells, Unit 912-5195 REASON: Blood product, collected under conditions where the sterility may have been compromised, was distributed. MANUFACTURER/RECALLING FIRM: United Blood Services-Tucson, Tucson, AZ RECALLED BY: Blood System, Inc., Scottsdale, AZ., by letter dated February 27, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 1 unit ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1849-1, Platelets, Unit 004-1741 REASON: Blood product, collected under conditions where the sterility may have been compromised, was distributed. MANUFACTURER: United Blood Services, Tucson, AZ RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by telephone on July 24, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: AZ QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1850-1, Red Blood Cells, Units GJ2711, GJ73965, GK15229, REASON: Blood product, collected under conditions where the sterility may have been compromised, was distributed. MANUFACTURER/RECALLING FIRM: Tri-Counties Blood Bank, Santa Barbara, CA RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by letter dated February 7, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 3 units ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1851-1, Red Blood Cells, Unit 24KC22384 B-1852-1, Recovered Plasma, Unit 24KC22384 REASON: Blood product, collected from a donor taking the drug Amantadine, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Louisville, KY RECALLED BY: By letter dated May 8, 2001. FIRM INITIATED RECALL: Conplete DISTRIBUTION: KY QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1855-1, Red Blood Cells, Leukocytes Reduced, Unit 22412-5755 REASON: Blood product that was out of controlled storage for more than 30 minutes was distributed. MANUFACTURER/RECALLING FIRM: Blood Systems, Inc., Las Vegas, NV RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by telephone on February 2, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: NV QUANTITY: 1 unit ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1856-1, Red Blood Cells, Leukocytes Reduced, Irradiated, Unit 22418- 6944 REASON: Blood product that was out of controlled storage for more than 30 minutes was distributed. MANUFACTURER: Blood Systems, Inc., Las Vegas, NV RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by telephone on November 17, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: NV QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1857-1, Red Blood Cells, Leukocytes Reduced, Irradiated, Units 13GC71452, 17KK77071, 17KK77074, 53GC28063, 53FN53992, 53GJ09954, 30GN19667, 30GN19643, 30GN19641, 30GN19666, and 53FQ72572 REASON: Blood products that were out of controlled storage for more than 30 minutes were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Atlanta, GA RECALLED BY: By letter dated March 2, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: GA QUANTITY: 11 units ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1858-1, Red Blood Cells, Leukocytes Reduced, Irradiated, Unit 11FM55571 REASON: Blood product that was out of controlled storage for more than 30 minutes was distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Southern Region, Atlanta, GA RECALLED BY: By telephone on February 23, 2000, and by letter dated March 1, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: GA QUANTITY: 1 unit _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1859-1, Red Blood Cells, Leukocytes Reduced, Irradiated , Units 17FH92548, 17FZ29358, 17FH92549, 17FH92637, 17FH92611, and 17FH92641 B-1860-1, Red Blood Cells, Irradiated, unit number 03H11727 REASON: Blood products that were out of controlled storage for more than 30 minutes were distributed. MANUFACTURER/RECALLING FIRM: The American National Red Cross, Southern Region, Atlanta, GA RECALLED BY: By telephone on February 28, 2000, and by letters dated March 2 and 13, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: GA QUANTITY: 7 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1861-1, Platelets Pheresis, Leukocytes Reduced, Units 03F10299, 03F10300 (two split units), 03F10301, 03F10302 (two split units), 03F10303, 03F10304, and 03F10305 REASON: Blood products, exposed to unacceptable storage temperatures, were distributed. MANUFACTURER/RECALLING FIRM: American Red Cross Blood Services, Valdosta, GA RECALLED BY: American National Red Cross, Atlanta, GA., by letter on July 18, 2000 and August 24, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: GA QUANTITY: 9 units ________________________________ RECALL NUMBER, PRODUCT AND CODE: B-1863-1, Red Blood Cells, Units 2641716 and 1371607 REASON: Blood products, that were incorrectly tested for Cytomegalovirus (CMV), were distributed. MANUFACTURER/RECALLING FIRM: LifeShare Blood Centers, Shreveport, LA RECALLED BY: By telephone on April 28, 1998. FIRM INITIATED RECALL: Complete DISTRIBUTION: LA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1881-1, Platelet, Pheresis, Leukocytes Reduced, Units 38P60619, 03KN11761 REASON: Blood products, which may have been stored at unacceptable temperatures, were distributed. MANUFACTURER/RECALLING FIRM: American National Red Cross, Atlanta, GA RECALLED BY: By telephone on May 4, 2000 and by letters dated May 23, 2000 and August 29, 2000. FIRM INITIATED RECALL: Complete DISTRIBUTION: GA QUANTITY: 2 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: B-1882-1, Fresh Frozen Plasma, Unit 084LP08970 REASON: Blood product, which had an incorrect collection time, was distributed. MANUFACTURER/RECALLING FIRM: American Red Cross, Oakland, CA RECALLED BY: By letter dated July 8, 1999. FIRM INITIATED RECALL: Complete DISTRIBUTION: CA QUANTITY: 1 unitRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0613-1 - Z-0618-1 Ventak Prism Automatic Implantable Cardioverter Defibrillators, VR Model 1850, VR HE Models 1852 and 1857, DR Model 1851, and DR HE Models 1853 and 1858. Codes: Serial Numbers: Ventak Prizm VR Model 1850: 103440-103442, 103447-103470, 103472-103473, 103475, 103479-103515, 103517-103847, 103849-103880, 103882-104235, 104237-104883, 104885- 104886, 104888, 104891-105008, 105010-105949, 105951-106009, 106012- 109299, 109301-109303, 109305-109845 Ventak Prizm DR Model 1851: 307946, 307972, 307976, 307988, 307995-308002, 308006-308007, 308009, 308011, 308016, 308019-308020, 308026-308028, 308030-308047, 308054, 308069-308075, 308077-308115, 308118-308146, 308148- 308155, 308158- 308269, 308271-308285, 308288-308309, 308311-308320, 308322-308326, 308328-308388, 308390-308406, 388408-308431, 308433- 308434,308436- 308437, 308439-308665, 308667-308699, 308701-308713, 308715-308747, 308749-308790, 308792-308825, 308827-388970, 308972-308989, 308991, 308993-309294, 309296-309509, 309511-309842, 309844-310083, 310085- 310095, 310098-310101, 310104-310105, 310108-310111, 310128-310175, 310177-310222, 310224-310225, 310227-310248, 310251- 310307, 310309- 310329, 310335-310337, 310341-310387, 310389-310409, 310411-310943, 310945-311423, 311425-312590, 312592-312815, 312817-313201, 313203-314612 Ventak Prizm VR HE Model 1852: 100000-100507 Ventak Prizm DR HE Model 1853: 300005-300011, 300013-300014, 300017, 300019-300020, 300022, 300031- 300033, 300035, 300037-300038, 300045-300063, 300065-300066, 300068- 300150, 300152, 300154-300280, 300282-300286, 300288-300317. 300319- 300324, 300326-301611 Ventak Prizm VR HE Model 1857: 500000-500123 Ventak Prizm DR HE Model 1858: 600000-600129 REASON: Devices could inappropriately go into Safety Mode limiting therapy. MANUFACTURER/RECALLING FIRM: Guidant Corporation, Cardiac Pacemakers, St. Paul, MN. RECALLED BY: Manufacturer, by letter dated April 23, 01 and by visit. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide and World wide. QUANTITY: 13,833 defibrillators _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-748-1, Infusion Pump. Model PC-1, 220V CE, with software versions 8.12 and 8.13, Marked “International Only”. REASON: The devices have the potential for a motor stall thereby affecting fluid delivery. MANUFACTURER/RECALLING FIRM: Alaris Medical Systems, Inc., San Diego, CA. RECALLED BY: Manufacturer, by letter on April 20, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Argentina, Australia, Chile, China, Hong Kong, Malaysia, Netherlands, New Zealand, Peru, Singapore, South Korea, United Kingdom. Also, U.S. Defense Department under contracts V797P-4091A and SP0200-98-D-8002. QUANTITY: 5820 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-757-1 Stryker Secure Med/Surg Bed, Model No. 3000-AC powered Hospital Bed; all units with serial numbers beginning with the first four digits 9505 through 9610. REASON: The fasteners which hold the side rails can loosen over time and make the side rail unstable, which may allow a patient to fall out of bed. MANUFACTURER/RECALLING FIRM: Stryker Corp., Kalamazoo, MI. RECALLED BY: Manufacturer, by service bulletin dated August 11, 1999. A second notice was sent on April 24, 2000. FIRM INITIATED RECALL: Complete. DISTRIBUTION: United States, Canada, Hong Kong, Mexico, Saudi Arabia, Ukraine, United Arab Emirates and the United Kingdom. QUANTITY: 5442 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-759-1 Cryovale Allograft Heart Valve. CODE: 6193676 REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by letter on June 27, 2001. FIRM INITIATED RECALL: Complete. DISTRIBUTION: PA QUANTITY: 1 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-760-1 - Cryovalve Allograft Heart Valve, Model No. AV00, Serial No. 3942406; Z-761-1 - Cryovalve Allograft Heart Valve, Model No. PV00, Serial No. 3942392. REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA RECALLED BY: Manufacturer, by letter on June 27, 2001. FIRM INITIATED RECALL: Complete. DISTRIBUTION: CA and FL QUANTITY: 2 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-762-1 - Cryovalve Allograft Heart Valve, Model No. AV00, Serial No. 6064264; Z-763-1 - Cryovalve Allograft Heart Valve, Model No. PV00, Serial No. 6064272 REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by letter on June 27, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NV and NM QUANTITY: 2 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-764-1 Cryovalve Allograft Heart Valve; Model No. PV00, Serial No. 6197116. REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by letter on July 2, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: CO QUANTITY: 1 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-765-1 Cryovalve Allograft Heart Valve, Model No. AV00, Serial No. 6105661. REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA RECALLED BY: Manufacturer, by letter on July 9, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: NV QUANTITY: 1 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-766-1 Cryovalve Allograft Heart Valve; Model No. AV00. Serial No. 3988317. REASON: The firm’s donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. MANUFACTURER/RECALLING FIRM: Cryolife, Inc., Kennesaw, GA RECALLED BY: Manufacturer, by telephone and letter on July 9, 2001. FIRM INITIATED RECALL: Complete DISTRIBUTION: IL QUANTITY: 1 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-767-1 Model SkinMaster System; CODE: SkinMaster MD7 Skin Rejuvenation System and SkinMaster Beauty Pro 5 System. REASON: The device failed to comply with 21 CFR 1040.11(a)(2) in that the units were introduced into commerce without safety labels and user information that comply with the Federal laser product performance standard, 21 CFR 1040.10 and 11. MANUFACTURER/RECALLING FIRM: Sybaritic Inc./Symedex LLC, Minneapolis, MN RECALLED BY: Manufacturer, by mailing of labels and revised user instructions to purchasers, reprinted sales brochure. To be completed by October 31, 2001.. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide. QUANTITY: 150 SkinMaster MD7 Skin Rejuvenation System units and 50 SkinMaster Beauty Pro 5 System units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-768-1 Gas machine for anesthesia. CODE: 4114586-001. REASON: Reports of unintended PEEP greater than 20 cmH20, all occurring at same hospital. MANUFACTURER/RECALLING FIRM: North American Drager, Telford, PA. RECALLED BY: Manufacturer, by letter. FIRM INITIATED RECALL: Complete. DISTRIBUTION: Nationwide and Canada. QUANTITY: 464 units. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0769-1 - Z-0771-1 E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203 CODES: a) E.CAM+ models with e.soft workstations, e.soft software versions 1.0 and above b) E.CAM Duet models with e.soft workstations, e.soft software versions 1.0 and above c) E.CAM+ models with ICON workstations, ICON software versions 8.0 and above all serial numbers with Coincidence mode package installed. REASON: Incorrect orientation of acquired patient data MANUFACTURER/RECALLING FIRM: Siemens Medical Systems, Inc. Hoffman Estates, IL. RECALLED BY: Manufacturer, by letter on 5/30/01. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide and Argentina, Brazil, Canada, China, Germany, Spain, Great Britain, Japan, Sweden, Turkey, Austria, Switzerland, Korea, Taiwan and the Netherlands. QUANTITY: 109 units. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0772-1/Z-0807-1 Baxter Interlink and Regular I.V. Sets; sterile, nonpyrogenic fluid path. CODES: a) Product code 2C5487, lot R212308 b) Product code 2C5493, lot R212373 c) Product code 2C5531, lots R211250, R211359, R211383,R211466, R211581 d) Product code 2C5543, lot R211565 e) Product code 2C5593, lot R211128 f) Product code 2C5641, lot U572784R g) Product code 2C6509, lot U571232R h) Product code 2C6511, lots U570747R, U570838R i) Product code 2C6519, lots R207191, R207266, R207357, R208678, R211334, R211417, R211599, R211623 j) Product code 2C6521, lot U569509R k) Product code 2C6537, lots R207167, R207209, R207217, R207225, R207233, R207308, R207324, R207340, R207381, R207456, R207522, R207654, R207712, R207852, R207969, R208017, R208066, R208645, R208686, R208744, R208785, R208835, R208843, R208884, R208934, R208959, R208983, R209007, R209031, R209049, R209130, R209163, R209213, R209312, R209445, R209585, R209684, R211136, R211201, R211300, R211367, R211433, R211516, R211672, R211730, R211755, R211813, R211946, R211979, R212001, R212035, R212092, R212134, R212142, R212167, R212217, R212316, R212324, R212365, R212415 l) Product code 2C6546, lots R208769, R208868, R208975, R209056, R211052, R211102, R212126, R212209 m) Product code 2C6571, lots R209148, R209239, R209338, R209452, R211276 n) Product code 2C6593, lots U570135R, U570192R, U570085R o) Product code 2C6606, lots R209023, R209072, R209080 p) Product code 2C6607, lots U569392R, U572156R q) Product code 2C6612, lots R207183, R207258, R207290, R210104, R210146 r) Product code 2C6723, lot U570531R s) Product code 2C6757, lots U569012R, U569228R, U569301R, U569863R, U570291R, U571828R, U571984R t) Product code 2C6891, lots U571570R, U571752R, U571943R, U573295R u) Product code 2C7542, lot U568303R v) Product code 2C7560, lots U571588R, U572347R w) Product code 2C7562, lots U568964R, U571364R, U571489R x) Product code 2C7564, lots U570440R, U570499R, U571273R, U571554R, U571968R, U572420R, U572479R y) Product code 2C7566, lots U570267R, U570317R, U571760R, U572511R z) Product code 2C7591, lot U571745R aa) Product code 2C7617, lots U568568R, U568873R, U572305R bb) Product code 2C9903, lot U568576R cc) Product code 2C9907, lot U569160R dd) Product code 2H6519, lots R210047, R210179, R210211 ee) Product code 2N3378, lots U573063R, U573451R, U573634R, U574012R, U574178R ff) Product code 2N9191, lot U568543R gg) Product code 3C0059, lot U573030R hh) Product code 4C7773, lot U568535R ii) Product code 4C7774, lot U568428R jj) Product code 4C7776, lot U569384R REASON: Pinholes in protector cap of luer lock. MANUFACTURER/RECALLING FIRM: Baxter Productos Medicos Ltd. Cartago, CR RECALLED BY: Baxter Healthcare Corp. Round Lake, IL., by letter dated June 25, 2001. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide and Canada, New Zealand, Australia and Japan. QUANTITY: 2,480,964 sets. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0859-1/Z-0860-1 Abbott LCx Probe System Chlamydia trachomatis Assay Amplification & Detection Kit; an in-vitro diagnostic. list 09B11 - U.S. labeling and list 07A91 - rest of world labeling CODES: list no.09B11 - U.S. labeling: lots 65731M300, 65738M300, 65739M300, 65740M300, 65741M300, 66518M100, 67421M100, 67956M200, 68579M200, 68580M200, 68581M200, 68744M200, 68748M200, 69246M100, 69403M100, 70681M200, 70683M200, 70685M200, 70686M200, 70687M200, 70688M200, 70689M200, 70784M300, 70785M300, 70786M300, 70787M300, 70788M300, 70790M300, 70793M300, 70983M300, 71040M200, 72249M200, 72264M200 list no. 07A91 - rest of world labeling: lots 65802M100, 66289M300, 66290M300, 67207M200, 67208M200, 67210M200, 67394M100, 67445M200, 68255M200, 68258M200, 69861M100, 69862M100, 70690M200, 70692M200, 70693M200, 70695M200, 70698M200, 70699M200, 72003M200, 72005M200, 72127M100, 72421M200, 72980M100 REASON: High negative control rates resulting in invalid runs and non-repeating positive. MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park , IL RECALLED BY: Manufacturer, by letter on 2/5/01. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide and Brazil, Canada, Great Britain, Japan, Hong Kong, Taiwan, Austalia, and New Zealand. QUANTITY: 37,957 kits. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0862-1 AxSYM B12 Reagent Pack (Dual Pack), list 3C79-20; an In Vitro diagnostic assay for the quantitative determination of vitamin B12. Codes: list 3C79-20, lots 71097M100 and 71098M100 REASON: Calibration failures and nonreproducible results. MANUFACTURER/RECALLING FIRM: Abbott Laboratories, Inc. Abbott Park, IL RECALLED BY: Manufacturer, by letter dated 3/14/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Canada, Australia, England, Hong Kong, New Zealand and Singapore. QUANTITY: 1549 kits _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0880-1 7F BioFlex Tesio Long Term Hemodialysis or Apheresis Catheter Set. CODE: Catalog # MCTC730K, Lot #M029230 REASON: Mislabeled - incorrect priming volume MANUFACTURER: Medical Components, Inc., Harleysville, PA RECALLED BY: Manufacturer, by letter on 1/19/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Argentina, Italy, Canada, Netherlands, and United Kingdom. QUANTITY: 91 trays ________________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0881-1-Z-0889-1, MEDCOMP BIO-FLEX CS CATHETER (CS100) CODES: Catalong #BFL-6 - lots: M813770, M819200, M820840, M902950, M903840, M907780, M915320M919550, M921320, M929930, M933270 and M936870. Catalog #BFR-6CTT (left side) - lots: M912540, M919140, M932310, and M934780. Catalog #BFR-6CTT (right side) - lots: M912550, M915330, M919130, M924550, M932320,M935480, M937950. Catalog #BFR-6 - lots: M728810, M801970, M809360,M813780, M819050, M819980, M820830, M900800, M902960, M03830, M904290, M904900, M907770, M918790, M918800, M921300, M922780, M924570, M927450, M933260, M936500, M937960. Catalog #BFR-70 - lot: M928700. Catalog #BFS-6 - lot: M834100, M903280, M912650, M914740, M927830, and M928340. Catalog #BFS-6CTT - lots: M912560, M931380 and M932530. Catalog #TRAY 452 - lots: M912380, M916450, M919100, M924370, and M933050. Catalog #TRAY 453 - lot: M912390. REASON: Longitudinal slits MANUFACTURER: Medical Components, Harleysville, PA RECALLED BY: Manufacturer, by fax 6/1/00 and follow up letter on 6/13/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: Hong Kong, Netherlands, Portugal, Hungary, Switzerland, Puerto Rico, united Kingdom, Sweden, and Thailand. QUANTITY: 22876 catheters _____________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0890-1 - Z-0892-1, Silicone catheters CODE: All lots. MANUFACTURER: MEDICAL COMPONENTS, INC., HARLEYSVILLE, PA REASON: Resent instructions for silicone catheters - not to use iodine RECALLED BY: Manufacturer, by letter dated 3/17/00 FIRM INITIATED RECALL: Completed DISTRIBUTION: Nationwide, Austria and Guam. QUANTITY: Unknown _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software, 5.1 CODE: Version 5.1 MANUFACTURER: DADE BEHRING, INC., NEWARK, DE REASON: Incorrect low results for a number of patient samples. RECALLED BY: Manufacturer, by letter 4/9/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 1696 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0914-1 - Z-0918-1 Pride Jazzy Scooter. CODES: 1100, 1104, 1120, 1170 and PHC1. REASON: Tire exploded MANUFACTURER: PRIDE MOBILITY PRODUCTS CORP., EXETER, PA RECALLED BY: Manufacturer, by safety alert notification on 12/8/00. .FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and England, Brazil, China, Belgium, Italy, Murcia, and Austrailia. QUANTITY: 61510 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0919-1, Z0921-1, Revo Scooter. CODES: SC60RRED (red), SC60RBLU (blue), and SC60RYEL (yellow). REASON: Scooter drive system may engage while parking brake is inactive MANUFACTURER/RECALLING FIRM: Shanghai Global Fabtech Plastic Products, Shanghai, China, RECALLED BY: Manufacturer, by safety alert on 5/18/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Liftgate, Ontario, Canada. QUANTITY: 1152 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0922-1 Drager Vapor 2000 Sevoflurane Vaporizers CODES: Catalog Number: 2000 Serial Numbers: ARPH-0485, ARPH-0484, ARPH-0483, ARPH-0482, ARPH-0481, ARPH-0480, ARPH-0473, ARPH-0470, and ARPH-0469. REASON: Mislabeled - Sevoflurane labeled as Isoflurane MANUFACTURER: DRAGER MEDIZINTECHNIK GMBH LUEBECK, RECALLED BY: North American Drager Telford, PA, by an MDR on 10/17/00. FIRM INITIATED RECALL: Complete DISTRIBUTION: PA QUANTITY: 3 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0923-1 - Z-0926-1 Percutaneous Sheath Introducer Kit. CODES: Catalog #AK-09800, Lots: RF0070524, RF0072194, RF0072195, RF0083177, RF0083178, RF0084453, RF0084454, RF0091533, and RF0091534. Catalog #AK-09801, Lots: RF0084462, RF0089390, and RF0080612. Catalog #AK-09803, Lots: RF0072212, RF0073195, and RF0084474. Catalog #AK-09880, Lot: RF0072232. REASON: Valve may leak under certain conditions MANUFACTURER: ARROW INTL., INC., READING, PA RECALLED BY: Manufacturer, by letter. on 4/26/01. FIRM INITIATED RECALL: Complete DISTRIBUTION: Nationwide and Bangkok, Canada, Helsinki, Tokyo. QUANTITY: 18170 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-929-1 Colleague Single Channel Volumetric Infusion Pumps, Codes: Product code 2M8151, all serial numbers less than 10110001CS. REASON: Battery related failures. MANUFACTURER/RECALLING FIRM: Baxter Healthcare Corporation, Singapore, SN. RECALLED BY: Baxter Healthcare Corp., I.V. Systems Division, Round Lake, IL by letter on 6/15/99. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide to hospitals. QUANTITY: 80,000 pumps _________________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0932-1, Disposable Scalpels labeled as sterile. CODE: Size 10 scalpels - Lot # 2410 Size 11 scalpels - Lot # 2412 Size 12 scalpels - Lot # 2293 Size 15 scalpels - Lot # 2428 Size 20 scalpels - Lot # 2399 REASON: Packaging defect (weld seals)/sterility may be compromised. MANUFACTURER/RECALLED BY: ZNC International Inc., Port Chester, NY. RECALLED BY: Manufacturer, by letter dated 6/26/01 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: NY , PA , OH , FL, MI, NC, IL, TX, WI . QUANTITY: Lot # 2410: 87 boxes; Lot # 2412: 400 boxes; Lot #2293: 100 boxes; Lot #2428: 500 boxes; Lot #2399: 39 boxes. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0934-1-Z-0937-1, Surgical accessories used for orthopedic or trauma surgery: saw blades, twist drill bits, burrs, and high speed burrs. All products contain a label that states “SSIS Inc. Date **Lot # ** Hos Part # ** Part Description: ** Product has been EO Gas sterilized.***” CODE: 3527 REASON: Sterility may be compromised. MANUFACTURER: Unknown RECALLED BY: Surgical Instrument Service & Savings, Inc. Sisters, OR, by telephone on 5/19/01 FIRM INITIATED RECALL: Complete DISTRIBUTION: OR. QUANTITY: 12 pkgs saw blades; 7 high speed burrs, 12 twist drill bits, 7 burrs _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0946-01, Z-0947-01, Servo Ventilator, 300/300A REASON: Failure of front panel potentiometers due to oxidation MANUFACTURER: Siemens Elema AB Solna, RECALLED BY: Manufacturer, issued a "URGENT DEVICE RECALL" ON 10/6/00. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 5273 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0948-01/Z-0949-01 Agilent Technologies (formerly Hewlett Packard Co.) (A)Anesthesia Monitoring Systems, M1165A, M1166A, M1167A, M1175A, M1176A, M1177A with Release C.0 software and Options A74, A76, A84, A86 specifying Care Models: 74S, 76S, 84S, 86S Firmware Revision level: Only EEPROM Nos.: M1059-81242 or M1059-81262 (B)Upgrade kits M1160A and M1170A with option LO1 Anesthesia Monitoring Systems, Models: M1165A, M1166A, M1167A, M1175A, M1176A, M1177A with Released C.0 software and Options A74, A76, A84, A86 specifying Care Models: 74S, 76S, 84S, 86S Firmware Revision level: Only EEPROM Nos.: M1059-81242 or M1059-81262 Upgrade kits M1160A and M1170A with option LO1 REASON: Monitoring and alarm functions maybe temporarily disabled MANUFACTURER: AGILENT TECHNOLGIES (HEWLETT-PACKARD GMBH) BOEBLINGEN, BADEN-WTTBG, RECALLED BY: Agilent Technologies, Inc., Andover, MA., by letter on 11/7/00 FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide, VA Medical Centers in CA, MO, GU, QUANTITY: 8 devices; 152 kits _____________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0976-1, Ash Split Catheter with cuffs. CODES: Batch Lot #: M001110, M006670, M006680, M006690, M007880, M017830, M903530, M906960, M907290, M907320, M908140, M909720, M911390, M911400, M911710, M911980, M912050, M912590, M913080, M913420, M913860, M914060, M914390, M914490, M914840, M916110, M917050, M918100, M918830, M918840, M918990, M919670, M920140, M920980, M921130, M921580, M922000, M922140, M922680, M923000, M926000, M926340, M926450, M930130, M930770, M930940, M931050, M931150, M931170, M931340, M931350, M931490, M931860, M932390, M932760, M932790, M932850, M933510, M933900, M934630, M935280, M936300, M940830, M942910, M943310, M944490, M909620, M914150, M916830, M932280, M912760, M932290, M003070, M005720, M008290, M011110, M011680, M014600, M019810, M021120, M914070, M914670, M916400, M916980, M918110, M918310, M918580, M918730, M919120, M919790, M920820, M921140, M922010, M926010, M926370, M930680, M931360, M931480, M931810, M932030, M932420, M932680, M933800, M934590, M936310, M936750, M940850, M006680, M006690, M903530, M911710, M911980, M912050, M913080, M914390, M914840, M918830, M918990, M919670, M921130, M922000, M922140, M922310, M922680, M923000, M926000, M926450, M927660, M931340, M931350, M931860, M932390, M932850, M933900, M935280, M936300, M940830, M944490, M912670, M921200, M923100, M005720, M916400, M918310, M918730, M919120, M919790, M920820, M921140, M922010, M926010, M926370, M927500, M931360, M931480, M932030, M932420, M932680, M933800, M934590, M936310, M936750, M940850, M923110, M914390, M002820, M007890, M904270, M911580, M913500, M914660, M915210, M922730, M925310, M926940, M929410, M931600, M932770, M935790, M942900, M004950, M009190, M918120, M920020, M922740, M924030, M925320, M927270, M932780, M936450, and M918310. REASON: Catheter fails to remain anchored to patient. RECALLED BY: MEDICAL COMPONENTS, INC., HARLEYSVILLE, PA FIRM INITIATED RECALL: Manufacturer, by letter dated 11/99. DISTRIBUTION: Nationwide QUANTITY: 43292 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1032-1, Animas R1000 Insulin Pump, 00-02688-01, 00-02864-01,00-02871-01, 00-02938-01, 00-02945-01, 01-02865- 01, 01-02872-01,01-02939-01, 02-02859-01, 02- 02866-01, 02-002873-01, 02- 02880-01, 03-02698-01, 03-02867-01, 03-02874-01, 04-02868-01, 04-02875-01, 04-02882-01, 05-02869-01, 05- 02876-01, 05-02883-01, 05-02890-01,06-02884-01, 07-02878-01, 07-02885-01, 07-02892-01, 09-02887-01,09-02894-01, 10-02888-01, 10-02895-01, 11-02889- 01, 11-02896-01,12-02897-01, 13-02898-01, 14-02899-01, 47-03002-01, 48- 03003-01, 48-03010-01, 49-03004-01, 49-03011-01, 50-03012-01, 50-03100-01, 51- 03013-01, 51-03101-01, 52-03014-01, 52-03021-01, 52-03102-01, 53-03008- 01, 53-03015-01, 53-03022-01, 53-03110-01, 54-03009-01, 54- 03111-01, 55-03017-01, 55-03024-01, 55-03105-01, 55-03112-01, 55-03200- 01, 56-03018-01, 56-03025-01, 56-03032-01, 56-03106-01, 56-03113-01, 56- 03120-01, 57-03026-01, 57-03033-01, 57-03040-01, 7-03114-01, 57-03121-01, 58-03027-01, 58-03034-01, 58-03108-01, 59-03028-01, 59-03035-01, 59- 03042-01, 59-03116-01, 59-03123-01, 59-03130-01, 59-03204-01, 60-03036-01, 60-03043-01, 60-03050-01, 60- 03117-01, 60-03131-01, 61-03037-01, 61-03044-01, 61-03118-01, 61-03125- 01, 62-03038-01, 62-03045-01, 62-03052-01, 62-03119-01, 62-03133-01, 63- 03039-01, 63-03046-01, 63-03053-01, 63-03127-01, 63-03134-01, 63-03141- 01, 64-03047-01, 64-03054-01, 64-03128-01, 64-03135-01, 65-03048-01, 65- 03055-01, 65-03062-01, 65-03129-01, 65-03150-01, 66-03049-01, 66-03056- 01, 66-03070-01, 66-03144-01, 67-03064-01, 67-03071-01, 67-03138-01, 68- 03058-01, 68-03072-01, 68-03139-01, 68-03146-01, 69-03059-01, 69-03066- 01, 69-03073-01, 69-03080-01, 69-03147-01, 69-03154-01, 70-03037-01, 70- 03074-01, 70-03081-01, 71-03068-01, 71-03082-01, 71-03149-01, 72-03069- 01, 72-03083-01, 73-03077-01, 73-03091-01, 73-03158-01, 73-03165-01, 74- 03078-01, 74-03085-01, 74-03092-01, 75-03079-01, 75-03086-01, 75-03093- 01, 76-02710-01, 76-03087-01, 76-03094-01, 77-02528-01, 77-03088-01, 78- 02617-01, 78-02712-01, 78-03089-01, 78-03184-01, 79-02706-01, 79-02720- 01, 79-02801-01, 79-03097-01, 80-02640-01, 80-03098-01, 80-03193-01, 81- 02708-01, 81-02722-01, 81-03099-01, 81-03187-01, 83-02629-01, 83-02900- 01, 84-02651-01, 84-02718-01, 84-02901-01, 85-02733-01, 85-02902-01, 86- 02639-01, 86-02808-01, 86-02815-01, 86-02822-01, 86-02903-01, 86-02910- 01, 87-02647-01, 87-02830-01, 87-02904-01, 87-02911-01, 88-02493-01, 88- 02736-01, 88-02824-01, 88-02905-01, 88-02912-01, 89-02670-01, 89-02744- 01, 89-02751-01, 89-02906-01, 89-02913-01, 89-02920-01, 90-02488-01, 90- 02745-01, 90-02819-01, 90-02907-01, 90-02914-01, 91-02908-01, 91-02915- 01, 91-02922-01, 92-02673-01, 92-02828-01, 92-02842-01, 92-02909-01, 92- 02916-01, 92-02923-01, 92-02930-01, 93-02667-01, 93-02917-01, 93-02924- 01, 93-02931-01, 94-02851-01, 94-02918-01, 94-02925-01, 94-02932-01, 95- 02852-01, 95-02919-01, 95-02926-01, 95-02940-01, 96-02589-01, 96-02691- 01, 96-02765-01, 96-02846-01, 96-02927-01, 96-02934-01, 96-02491-01, 97- 02692-01, 97-02854-01, 97-02861-01, 97-02928-01, 97-02942-01, 98-02686- 01, 98-02767-01, 98-02848-01, 98-02862-01, 98-02943-01, 99-02863-01, 99- 08270-01, 99-02937-01, and 99-02944-01. REASON: Infusion pumps may have defective vents causing unintentional dose of insulin MANUFACTURER: Animas Corporation, Frazer, PA RECALLED BY: Manufacturer, by telephone on 4/3/01. By letters on 4/4-5/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide QUANTITY: 239 unitsRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0699-1 OncoSeed Iodine 125 Seeds; a welded titanium capsule containing Iodine-125 absorbed onto a silver rod. CODE: Model 6711, lot E9448C. REASON: Mislabeled seeds. MANUFACTURER/RECALLING FIRM: Medi-Physics, Inc. dba Nycomed Amersham Imaging, Arlington Heights, IL. RECALLED BY: Manufacturer, by telephone on 6/14/01 and letter on 6/15/01. FIRM INITIATED RECALL: Complete. DISTRIBUTION: AL. QUANTITY: 110 seeds. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-751-1 A.T.S. Reusable Tourniquet Cuffs, Velcro Component, Part No. 650199, Lot Nos. 92299500, 92308600, 92313500, 92313600, 92313700, 92322200, 92322300, 92322400, 92322500, 92322600, 92322700, 92323000, 92323100, 92327600, 92328000, 92328100, 92328200, 92328500, 92328600; REASON: The Velcro hook fastener component tore during use. Internal tensile strength testing showed that the Velcro component had approximately half of the tensile strength of a normal product. MANUFACTURER/RECALLING FIRM: Zimmer, Inc., Statesville, NC. RECALLED BY: Manufacturer, by letter on February 23, 2001. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and to Spain, Germany, France, Belgium, England, Denmark, Italy, Finland, Singapore, Latin America, Israel, Middle East, Canada, Australia, Japan and Korea. QUANTITY: 3124 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-758-1 PRESS MATE Advantage Vital Sign Monitor. Models 9861, 9871 CODE: Serial Numbers 310004 through 311135 REASON: The monitor may display erratic respiration rates and cause a false or no alarm. MANUFACTURER/RECALLING FIRM: COLIN CORP. Komaki City, Japan RECALLED BY: Colin Medical Instruments Corp., San Antonio, TX., by letter dated 4/3/01 . FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide QUANTITY: 963 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-864-1 Vitros Clinical Chemistry Cholesterol (CHOL) Slides, Coating 0309, Catalog No. 1669829, Lot Numbers: 0823-0309-7912 0823-0309-8001 0823-0309-8002 0823-0309-8069 0823-0309-8070 0823-0309-8071 0823-0309-8108 0823-0309-8109 0823-0309- 8232 0823-0309-8233 0823-0309-8234 0823-0309-8236 0823-0309-8243 0823- 0309-8244 0823-0309-8343 0823-0309-8344 0823-0309-8345 0823-0309-8378 0823-0309-8379 0823-0309-8445 0823-0309-8446 0823-0309-8447 0823-0309- 8457 0823-0309-8552 0823-0309-8553 0823-0309-8614 0823-0309-8615 0823- 0309-8627 0823-0309-8628 0823-0309-8629 0823-0309-8672 0823-0309-8673 0823-0309-8675 0823-0309-8676 0823-0309-8677 0823-0309-8702 0823-0309- 8703 0823-0309-8704 0823-0309-8762 0823-0309-8763 REASON: The use of the referenced product may result in positively biased results at high concentrations. MANUFACTURER/RECALLING FIRM: Ortho-Clinical Diagnostics, Inc., Rochester, NY. RECALLED BY: Manufacturer, by letter on 5/11/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: Nationwide and Australia, Canada, France, Germany, India, Italy, Portugal, Singapore and the UK QUANTITY: 12,620 packs-domestic; and 8,603 packs-international _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-865-1 Vitros Clinical Chemistry Specialty Diluent, Catalog No. 8559825, Lot No. Y1844. REASON: Product is labeled with the incorrect expiration date of 31 May 2003. The correct expiration date is 31 May 2002. MANUFACTURER/RECALLING FIRM: Ortho-Clinical Diagnostics, Inc., Rochester, NY. RECALLED BY: Manufacturer, by telephone calls on 6/14/01 followed by letters. FIRM INITIATED RECALL: Terminated DISTRIBUTION: CA, FL, KS, MA, NY, OK, PA, SD, TX, VT, and WI. Product was shipped to three government facilites under contract #V797P-6565A. 1) Ellsworth AFB, SD 2) Walter Reed Army Med. Ctr., Washington, DC 3) Columbus AFB, Columbus, MS QUANTITY: 48 boxes _______________________________ RECALL NUMBER, PRODUCT AND CODE: Plastic Material (Buttons) used to make Rigid Gas Permeable Contact Lenses: Z-893-1 - Boston II (oprifocon A) Green. Product No.1000-A, Lot No. 00264PTC001, Rigid Gas Permeable Lens for Daily Wear; Z-894-1 - Boston Equalens II (itafocon A) Green wit UV, Product No. 1500-A, Lot Nos. 00214PTC003, 99279PTC004, 99279PTC005, 99279PTC006, Rigid Gas Permeable Contact Lenses for Daily Wear or Extended Wear; Z-895-1 - Boston ES (enflufocon A) Green with UV, Product No. 2200- A, Lot Nos. 00236PTC001, 00264PTC002, Rigid Gas Permeable Contact Lenses; Z-896-1 - Boston ES (enflufocon A) Gray with UV, Product No. 2200- G, Lot No. 00236PTC002, Rigid Gas Permeable Contact Lenses; Z-897-1 - Boston XO (hexafocon A) Green with UV, Product No. 2300-A, Lot Nos. 00040PTC013, 00040PTC014, 00040PTC015, 00165PTC008, 00278PTC006, Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lenses for Daily Wear; Z-898-1 - Boston EO (enflufocon B) Green with UV, Product No. 2600- A, Lot Nos. 00222PTC006, 00313PTC002, Rigid Gas Permeable Contact Lenses. REASON: The contact lenses contained D&C Yellow No. 11 which is not approved for contact lens use. MANUFACTURER/RECALLING FIRM: Polymer Technology (A Bausch & Lomb, Inc. Co.) Rochester, NY. RECALLED BY: Manufacturer, by Letter dated March 30, 2001. FIRM INITIATED RECALL: Complete. DISTRIBUTION: Nationwide and worldwide. QUANTITY: 92,455 units _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0906-1 Behring Coagulation System (BCS) software version 2.2. CODES: Model OVIO03 Version 2.2 REASON: Leak of piston pump valve introduces air bubbles. MANUFACTURER/RECALLING FIRM: Dade Behring Marburg GMBH Marburg RECALLED BY: Dade Behring, INC., Newark, DE., by letter on January 3, 2001. FIRM INITIATED RECALL: Complete. DISTRIBUTION: NY, IL and MI. QUANTITY: 3 units. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0908-1/ Z-0912/1 Five Dimension RxL Flex Reagent Cartridges. The product is composed of 1) Ferritin (FERR), 2) Human Chorionic Gonadotropin (HCG), 3) Mass Creatine Kinase MB Isoenzyme (MMB), 4) Myoglobin, and 5) Prostate Specific Antigen (PSA). FERR has 120 tests/carton; 30 tests/cartridge. HCG has 120 tests/carton; 30 tests/cartridge. MMB has 160 tests/carton; 40 tests/cartridge. MYO has 120 tests/carton; 30 tests/cartridge. PAS has 120 tests/carton; 30 tests/cartridge. The product is sold by the cartridge or 4 cartridges per carton. CODES: FERR Lot FR9351 exp. 12/17/99, FERR Lot IR0063 exp. 3/3/99, HCG Lot HP0177 exp. 6/25/00, MMB Lot FP0100 exp. 4/9/00, MMB Lot HN0178 exp. 6/26/00, MMB WA0190 exp. 7/8/00, MYO Lot FP0074 exp. 3/14/00, MYO Lot FN0074 exp. 3/14/00, PSA Lot WA0253 exp. 9/9/00, and PSA Lot HP0239 exp. 8/26/00. REASON: Decline in stability following hydration. MANUFACTURER/RECALLING FIRM: Dade Behring, Inc., Newark, DE. RECALLED BY: Manufacturer, by letter on 10/05/1999. FIRM INITIATED RECALL: Complete. DISTRIBUTION: Nationwide and Germany, Australia, Canada, and Belgium. QUANTITY: 6447. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-930-1 Canon CXDI-22 X-Ray Digital Radiography System; CODE: Serial Numbers: 200001 through 200037 (except 200036). REASON: The exposure function may fail due to a blown fuse. MANUFACTURER/RECALLING FIRM: Canon U.S.A., Inc., Lake Success, NY. RECALLED BY: Manufacturer, by letters, dated 7/3/01 and 7/5/01. FIRM INITIATED RECALL: Ongoing DISTRIBUTION: NJ, NY, NC, OH, FL, WA, CA, TX, HI. QUANTITY: 27 _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0933-1 IMMULITE 2000 Antithyroid peroxidase (Anti TPO) kit, Catalog Number L2KTO2 121. CODE: Immulite 2000 Antithyroid Peroxidase (TPO), kit lot L2KT02 121. REASON: Component mix-up. Wrong bead lot. MANUFACTURER/RECALLING FIRM: Euro DPC United Kingdom. RECALLED BY: Diagnostic Products Corp., Los Angeles, CA., by letter on 7/11/2001. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: AZ, CA, NY, NJ, OR, MI, NM, MO, Korea and Japan. QUANTITY: 55. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0938-1 MicroBioLogics Streptococcus bovis, Derivative of ATCC# 49147, Catalog Numbers 0631V, 0631S, and 0631P. This product was packaged into 3 packaging configurations under the MicroBioLogics brand name: 1. Catalog number 0631V - A single vial that contains 10 individual LYFO-Disk pellets streptococcus bovis. 2. Catalog number 0631S - A canster with 10 individual KWIK-STIK units of streptococcus bovis. 3. Catalog number 0631P - A wrapped set that contains 2 individual KWIK- STIK units of streptococcus bovis. Packaging configurations 2 and 3 are labeled for a private label distributor, PML Microbiologicals, Wilsonville, OR. That name and address appears at the top of the label, with the product identification below. Recalled product in a fourth packaging configuration was made and labeled for HealthLink. It is individually-wrapped Kwik-Stik labeled “HealthLink***Cat # HL3480 (49147) S. bovis”. HealthLink is located in Jacksonville, FL. CODE: Lot numbers 63131 and 63132. REASON: The product contains the wrong bacteria strain. MANUFACTURER/RECALLING FIRM: MicroBioLogics, Inc., St. Cloud, MN. RECALLED BY: Manufacturer, by telephone on 2/19/01 and letter dated 2/19/01. FIRM INITIATED RECALL: Complete. DISTRIBUTION: Nationwide, Canada and South Africa. QUANTITY: 462 bacteria pellets, packaged 1-10 per package. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0951-1 EasyBlood Gas Analyzer. CODES: EasyBlood Gas Analyzers with Software version below M4.20. REASON: PCO2 and PO2 values are incorrect if displayed in SI units instead of mmHg. MANUFACTURER/RECALLING FIRM: Medica Corp., Bedford, MA. RECALLED BY: Manufacturer, by fax on 8/15/00. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Malaysia, Russia, Hong Kong, Switzerland, Argentina, Czech Republic, Canada, Hungary, Chile Finland, Turkey, Italy, South Africa, Korea, Pakistan, Greece, Portugal, Mexico, Venezuela, Philippines, Bangladesh. QUANTITY: 229. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0966-01 Vaxcel 5F SL PICC(Peripherally Inserted Central Cannula), Clampable Hub Catalog #45-443, Lot Number 005827 Codes: Vaxcel 5F SL PICC(Peripherally Inserted Central Cannula), Clampable Hub, 60 cm Wire Catalog #45-443, Lot Number 005827. REASON: Product may not have a clampable hub. MANUFACTURER/RECALLING FIRM: Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT. RECALLED BY: MEDI TECH, a division of Boston Scientific Corp. Watertown, MA., on 3/9/01 by Certified Mail. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide to Medical Centers. QUANTITY: 699. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0970-1/Z-0971-1 Wako Lyophilized Chemistry 2, Product Code 7707A, Lot 7707A01, MFD Mar-00, Exp Date 31 Mar 2003; Wako Lyophilized Chemistry 1, Product Code 1104A, Lot Number 7704A01, MFD Mar-00, Exp Date 31 Mar 2003 REASON: Unit recalled by component manufacturer due to positive for anti-HCV MANUFACTURER/RECALLING FIRM: Bio-Rad Laboratories, Inc. Irvine, CA. RECALLED BY: Manufacturer, by letter dated 01/10/01. FIRM INITIATED RECALL: Complete. DISTRIBUTION: Japan. QUANTITY: Unknown. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-0978-1 Bard InLay Ureteral Stent, 4.7 Fr. Diameter. CODES: Catalog Number 777424 - Lot Number 07BK2302 Catalog Number 777426 - Lot Number 07GK0081. REASON: Packaged with wrong guidewire. MANUFACTURER/RECALLING FIRM: Bard Glens Falls Operation, Queensbury, NY. RECALLED BY: C. R. Bard, Inc. Covington, GA., by letter on 11/13/00. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide. QUANTITY: 150 Units. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1023-1 Diamedix/immunosimplicity brand of anti-Sm/RNP Enzyme Immunoassay Test Kit, For in Vitro Diagnostic Use, 96 test kit, catalog No. 720-270. CODES: 50700Z, Expiration date of April 2001. REASON: Positive control failed to recover within its assigned range. MANUFACTURER/RECALLING FIRM: Diamedix Corp, Miami, FL. RECALLED BY: Manufacturer, by letter on 01/05/01. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: NY and IL. QUANTITY: 13. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1024-1 / Z-1026-1 Sunsoft Additions contact lenses, Sunsoft Multiples Toric, and Sunsoft Sphere Multiples. CODES: Various lot numbers and sequences. REASON: Contact lenses may vary from the labeled power by as much as 0.75 diopters. MANUFACTURER/RECALLING FIRM: Sunsoft Corp., Albuquerque, NM. RECALLED BY: Manufacturer, by letter on 11/3/00 and 11/6/00. FIRM INITIATED RECALL: Complete. DISTRIBUTION: Nationwide and Canada, Denmark, France, Germany, Netherlands, Norway, Portugal, Sweden, and Turkey. QUANTITY: 892 lenses. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1047-1 Premier Human Lyme EIA, an in-vitro diagnostic test kit. The kits should contain 2 microplates containing 96 test wells per plate. Kits are packaged and sold individually. CODES: Lot #696032.018. REASON: The kits are packaged with less test wells than labeled. MANUFACTURER/RECALLING FIRM: Meridian BioScience, Inc., Cincinnati, OH. RECALLED BY: Manufacturer, by letter, dated 7/2/01. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: CT, IA, MD, MA, NJ, VA, and Belgium. QUANTITY: 151 kits. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1055-1 Premier EBV IgG ELISA, in-vitro diagnostic test kits, packaged under the Gull label. CODES: Catalog Number: EBE100. REASON: Microwells that are washed automatically may result in an invalid test assay. MANUFACTURER/RECALLING FIRM: Meridian Diagnostics, Inc., Cincinnati, OH. RECALLED BY: Manufacturer, by telephone and fax on 2/7/01. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: Nationwide. QUANTITY: 946 kits. _______________________________ RECALL NUMBER, PRODUCT AND CODE: Z-1059-1 MRO Reverse Osmosis (RO) Water Treatment System. CODE: All MRO Hemodialysis RO Water Treatment Systems. REASON: Defective sensor will result in a false high conductivity reading and trigger alarm. MANUFACTURER/RECALLING FIRM: Ameriwater, Dayton, OH. RECALLED BY: Manufacturer, by Quality Advisory Notice, dated 2/17/98 and fax and telephone on 11/7/00. FIRM INITIATED RECALL: Ongoing. DISTRIBUTION: NY. QUANTITY: 59 units.END OF ENFORCEMENT REPORT FOR SEPTEMBER 5, 2001. ####
Office of Public Affairs
Hypertext uploaded by tg 2001-SEPT-05.